ISORAY MEDICAL, INC.

Address:350 Hills St Ste 106,RICHLAND,WA,99354,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Source, Brachytherapy, Radionuclide (KXK) (1)

Premarket Exempt

No Yes

Clear

PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI Marker - M748PL80 Catalog Number :

Device Description : The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.

Device Class : 2

Duns Number: 113577485

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

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